| Outcome Measures: |
Primary: Placebo-adjusted, Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus), Baseline (result closest prior to dosing on Day 1), Week 32|Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 32: Cohort 2 (Obesity), Body weight was measured using a calibrated weighing scale., Baseline (result closest prior to dosing on Day 1), week 32 | Secondary: Percentage of Participants Who Achieved HbA1C <7% at Week 32: Cohort 1 (Type 2 Diabetes Mellitus), Baseline (result closest prior to dosing on Day 1), Week 32|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus), Baseline (result closest prior to dosing on Day 1), Week 32|Percent Change From Baseline in Body Weight at Week 32: Cohort 1 (Type 2 Diabetes Mellitus), Body weight was measured using a calibrated weighing scale., Baseline (result closest prior to dosing on Day 1), Week 32|Placebo-adjusted, Change From Baseline in HbA1C in the Rybelsus Arm at Week 32: Cohort 1 (Type 2 Diabetes Mellitus), This outcome measure was planned to be analyzed only for rybelsus arm and placebo arm as pre-specified in the protocol., Baseline (result closest prior to dosing on Day 1), Week 32|Percentage of Participants Achieving >=5%, >=10%, and >=15% Body Weight Loss at Week 32 Relative to Baseline: Cohort 2 (Obesity), Baseline (result closest prior to dosing on Day 1), Week 32|Absolute Change From Baseline in Waist Circumference at Week 32: Cohort 2 (Obesity), Waist circumference was measured at midpoint, between lower margin of last palpable rib and top of iliac crest (approximately 1 inch \[2.54 centimeter {cm}\] above the navel). It was measured by using an anthropometric tape (stretch-resistant)., Baseline (result closest prior to dosing on Day 1), Week 32|Absolute Change From Baseline in Waist-to-hip Ratio at Week 32: Cohort 2 (Obesity), The hip circumference was defined as the circumference around the widest portion of the buttocks. Waist circumference was measured at midpoint, between lower margin of last palpable rib and top of iliac crest (approximately 1 inch \[2.54 cm\] above the navel). The measurements were performed using an anthropometric tape (stretch-resistant)., Baseline (result closest prior to dosing on Day 1), Week 32|Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 32: Cohort 2 (Obesity), HOMA-IR was calculated as: fasting plasma insulin (\[FPI\]\*(FPG)/405 and measured in terms of mg/dL\* (milliunits per liter)., Baseline (result closest prior to dosing on Day 1), Week 32|Change From Baseline in Homeostatic Model Assessment for Insulin Sensitivity (HOMA-S) at Week 32: Cohort 2 (Obesity), HOMA-S was calculated as (22.5/\[FPI\] \* FPG) \*100 and measured in terms of percentage sensitivity., Baseline (result closest prior to dosing on Day 1), Week 32|Number of Participants With Treatment Emergent Adverse Events (TEAEs): Cohort 1 (Type 2 Diabetes Mellitus), An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred on or after the first dose of treatment but before the last dose plus lag time., From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)|Number of Participants With Treatment Emergent Adverse Events (TEAEs): Cohort 2 (Obesity), An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred on or after the first dose of treatment but before the last dose plus lag time., From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)|Number of Participants With Serious Adverse Events (SAEs): Cohort 1 (Type 2 Diabetes Mellitus), SAE defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic; other important medical events., From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)|Number of Participants With Serious Adverse Events (SAEs): Cohort 2 (Obesity), SAE defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic; other important medical events., From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)|Number of Participants Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 1 (Type 2 Diabetes Mellitus), \\ An AE was any untoward medical occurrence in a participants or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs leading to permanent discontinuation from study were those with an AE record indicating the AE caused permanent discontinuation from the study. AEs leading to permanent discontinuation from study treatment were those AEs with an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study., From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)|Number of Participants Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 2 (Obesity), An AE was any untoward medical occurrence in a participants or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs leading to permanent discontinuation from study were those with an AE record indicating the AE caused permanent discontinuation from the study. AEs leading to permanent discontinuation from study treatment were those AEs with an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study., From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)|Number of Participants With Hypoglycemic Adverse Events (HAE) According to Titration Dose: Cohort 1 (Type 2 Diabetes Mellitus), Glucose values were monitored using glucometer. Hypoglycemia =plasma/blood glucose value of \<70 mg/dL (3.9 millimoles per liter \[mmol/L\]). Severe HAE: Participant was unable to treat him/herself due to neurological impairment (not age) and required assistance of another person, at least one neurological symptom of memory loss, confusion, uncontrolled behavior etc. Either documented blood glucose\<=54 mg/dL (2.7 mmol/L). Documented symptomatic: An event during which symptoms of HAE were accompanied with plasma/blood glucose \<70 mg/dL and prompt resolution with food intake, SC glucagon, or IV glucose. Probable symptomatic HAE: An event during which symptoms of an HAE were not accompanied by a plasma glucose determination but was presumably caused by a plasma glucose concentration \<70 mg/dL and prompt resolution with food intake, SC glucagon, or IV glucose. Asymptomatic: An event not accompanied by typical symptoms of an HAE, but a plasma/blood glucose value of \<70 mg/dL was reported., Up to week 28|Number of Participants With Hypoglycemic Adverse Events According to Titration Dose: Cohort 2 (Obesity), Glucose values were monitored using glucometer. Hypoglycemia =plasma/blood glucose value of \<70 mg/dL (3.9 mmol/L). Severe HAE: Participant was unable to treat him/herself due to neurological impairment (not age) and required assistance of another person, at least one neurological symptom of memory loss, confusion, uncontrolled behavior etc. Either documented blood glucose\<=54 mg/dL (2.7 mmol/L). Documented symptomatic: An event during which symptoms of HAE were accompanied with plasma/blood glucose \<70 mg/dL u and prompt resolution with food intake, SC glucagon, or IV glucose. Probable symptomatic HAE: An event during which symptoms of an HAE were not accompanied by a plasma glucose determination but was presumably caused by a plasma glucose concentration \<70 mg/dL and prompt resolution with food intake, SC glucagon, or IV glucose. Asymptomatic: An event not accompanied by typical symptoms of an HAE, but a plasma/blood glucose value of \<70 mg/dL was reported., Up to week 28|Number of Participants With Vital Sign Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus), Vital signs included blood pressure and pulse rate and were measured with the participants in a seated position after at least 5 minutes of rest for the participant. Criteria for abnormalities included: Systolic Blood Pressure (millimeter of mercury \[mmHg\]): value more than (\>) 200 and value less than (\<) 90; Diastolic blood pressure: value \> 100 and \< 40; Pulse rate: (beats per minute \[BPM\]): value \< 40 and \> 110., Up to week 28|Number of Participants With Vital Sign Abnormalities: Cohort 2 (Obesity), Vital signs included blood pressure and pulse rate and were measured with the participants in a seated position after at least 5 minutes of rest for the participant. Criteria for abnormalities included: Systolic blood pressure (mmHg): value \> 200 and value \< 90; Diastolic blood pressure: value \> 100 and \< 40; Pulse rate: (BPM): value \< 40 and \> 110., Up to week 28|Number of Participants With Clinical Laboratory Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus), Hematology: platelets (10\^9/L)\< 0.5\*lower limit of normal (LLN); leukocytes\< 0.6\*LLN and \>1.5\*upper limit of normal (ULN); lymphocytes and neutrophils \<0.8\*LLN and \>1.2\*ULN; basophils, eosinophils, monocytes:\>1.2\*ULN; prothrombin time (sec) \>1.1\*ULN; prothrombin international normalized ratio \>1.1\*ULN; clinical chemistry: bilirubin (mg/dL), indirect bilirubin:\>1.5\*ULN; aspartate and alanine aminotransferase, gamma glutamyl transferase (U/L):\>3.0\*ULN; urea nitrogen and creatinine (mg/dL)\>1.3\* ULN;HDL cholesterol (mg/dL)\<0.8\*LLN; LDL (mg/dL)\>1.2\*ULN, Triglycerides (mg/dL):\>1.3\*ULN; Potassium (milliequivalents per liter) \< 0.9\*LLN and \> 1.1\* ULN; calcium (mg/dL)\< 0.9\*LLN, Thyroxine (nanograms/dL\<0.8\*LLN and \>1.2\*ULN, HbA1C (%)\>1.3\*ULN; Amylase, Lipase (U/L) and Glucose -Fasting (mg/dL)\>1.5\*ULN; urinalysis: pH\> 8; urine glucose, ketones, protein, hemoglobin, nitrite and leukocyte esterase\>=1. Number of participants with abnormalities in any of the laboratory parameters is reported., Up to week 28|Number of Participants With Clinical Laboratory Abnormalities: Cohort 2 (Obesity), Hematology: platelets (10\^9/L)\< 0.5\* LLN; leukocytes\< 0.6\*LLN and \>1.5\*ULN; lymphocytes and neutrophils \<0.8\*LLN and \>1.2\*ULN; basophils, eosinophils, monocytes:\>1.2\*ULN; prothrombin time (sec) \>1.1\*ULN; prothrombin international normalized ratio \>1.1\*ULN; clinical chemistry: bilirubin (mg/dL), indirect bilirubin:\>1.5\*ULN; aspartate and alanine aminotransferase, gamma glutamyl transferase (U/L):\>3.0\*ULN; urea nitrogen and creatinine (mg/dL)\>1.3\* ULN;HDL cholesterol (mg/dL)\<0.8\*LLN; LDL (mg/dL)\>1.2\*ULN, Triglycerides (mg/dL):\>1.3\*ULN; Potassium (milliequivalents per liter) \< 0.9\*LLN and \> 1.1\* ULN; calcium (mg/dL)\< 0.9\*LLN, Thyroxine (nanograms/dL\<0.8\*LLN and \>1.2\*ULN, HbA1C (%)\>1.3\*ULN; Amylase, Lipase (U/L) and Glucose -Fasting (mg/dL)\>1.5\*ULN; urinalysis: pH\> 8; urine glucose, ketones, protein, hemoglobin, nitrite and leukocyte esterase\>=1. Number of participants with abnormalities in any of the laboratory parameters is reported., Up to week 28|Number of Participants With ECG Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus), Standard 12-lead ECGs were performed after the participant had rested quietly for more than 10 minutes in a supine position utilizing an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QT interval corrected using Fridericia's formula (QTcF), and QRS complex. ECG abnormalities were categorized as: PR interval (milliseconds \[msec\]), Value \>= 300; percent change (%Chg) greater than equal (\>=) 25/50%. QRS duration (msec): Value \>= 140 and %Chg \>= 50%. QT interval (msec): Value \> 500; QTCF interval (msec): 450 \< Value \<= 480, 480 \< Value \<= 500, Value \> 500; 30 \<= Change (Chg) \<= 60; Chg \> 60., Up to week 28|Number of Participants With ECG Abnormalities: Cohort 2 (Obesity), Standard 12-lead ECGs were performed after the participant had rested quietly for more than 10 minutes in a supine position utilizing an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF, and QRS complex. ECG abnormalities were categorized as: PR interval msec, Value \>= 300; percentage change (%Chg) \>= 25/50%. QRS duration (msec): Value \>= 140 and %Chg \>= 50%. QT interval (msec): Value \> 500; QTCF interval (msec): 450 \< Value \<= 480, 480 \< Value \<= 500, Value \> 500; 30 \<= Change (Chg) \<= 60; Chg \> 60., Up to week 28|Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS) Category: Cohort 2 (Obesity) Only, C-SSRS is an interview-based rating scale to assess suicidal ideation and suicidal behavior and had a binary response (yes/no). C-SSRS data was mapped to C-CASA per Guidance for Industry: Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials. A participant was said to have suicidal behavior in case of any of following events: 1) completed suicide; 2) suicide attempt; or 3) preparatory acts toward imminent suicidal behavior. A participant showed suicidal ideation if they responded 'yes' to any of the 5 questions, 'Wish to be dead; Non-Specific Active Suicidal Thoughts Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent. The participant was said to exhibit Self-injurious behavior, no suicidal intent if they responded as Yes to 'Has participant engaged in Non-suicidal Self-Injurious Behavior, Baseline (result closest prior to dosing on Day 1), anytime post-baseline (Up to Week 28) | Other: Placebo-adjusted, Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) at Week 16: Cohort 1 (Type 2 Diabetes Mellitus), Analysis was performed using mixed model repeated measures (MMRM) model including treatment, gender strata and time as fixed effects, baseline\*time interaction, time\*treatment interaction, and baseline as a covariate with time fitted as a repeated effect and participant as a random effect., Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16|Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 20: Cohort 2 (Obesity), Body weight was measured using a calibrated weighing scale. Analysis was performed using MMRM model including treatment, gender strata and time as fixed effects, baseline\*time interaction, time\*treatment interaction, and baseline as a covariate with time fitted as a repeated effect and participant as a random effect., Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 20|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16: Cohort 1 (Type 2 Diabetes Mellitus), Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16|Percent Change From Baseline in Body Weight at Week 16: Cohort 1 (Type 2 Diabetes Mellitus), Body weight was measured using a calibrated weighing scale., Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16|Placebo-adjusted, Change From Baseline in Percentage of HbA1C in the Rybelsus Arm Versus Placebo Arm at Week 16: Cohort 1 (Type 2 Diabetes Mellitus), Analysis was performed using MMRM model including treatment, gender strata and time as fixed effects, baseline\*time interaction, time\*treatment interaction, and baseline as a covariate with time fitted as a repeated effect and participant as a random effect. This outcome measure was planned to be analyzed only for rybelsus arm and placebo arm as pre-specified in the protocol., Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16|Absolute Change From Baseline in Waist Circumference at Week 12 and 24: Cohort 2 (Obesity), Waist circumference was measured at midpoint, between lower margin of last palpable rib and top of iliac crest (approximately 1 inch \[2.54 cm\] above the navel). It was measured by using an anthropometric tape (stretch-resistant)., Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], Week 12, 24|Absolute Change From Baseline in Waist-to-hip Ratio at Week 12 and Week 24: Cohort 2 (Obesity), The hip circumference was defined as the circumference around the widest portion of the buttocks. Waist circumference was measured at midpoint, between lower margin of last palpable rib and top of iliac crest (approximately 1 inch \[2.54 cm\] above the navel). The measurements were performed using an anthropometric tape (stretch-resistant)., Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], week 12, 24|Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 16: Cohort 2 (Obesity), HOMA-IR was calculated as: (\[FPI\]\*(FPG)/405 in terms of Mg/dL\* (milliunits per liter)., Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16|Change From Baseline in Homeostatic Model Assessment for Insulin Sensitivity (HOMA-S) at Week 16: Cohort 2 (Obesity), HOMA-S was calculated as (22.5/\[FPI\]\*FPG)) \*100 and measured in terms of. percentage sensitivity., Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16
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| Locations: |
Trinity Clinical Research, Centreville, Alabama, 35042, United States|Anaheim Clinical Trials, LLC, Anaheim, California, 92801, United States|San Fernando Valley Health Institute, Canoga Park, California, 91304, United States|Catalina Research Institute, LLC, Montclair, California, 91763, United States|Empire Clinical Research, Pomona, California, 91767, United States|University Clinical Investigators, Inc., Tustin, California, 92780, United States|Diablo Clinical Research, Inc., Walnut Creek, California, 94598, United States|Innovative Research of West Florida, Clearwater, Florida, 33756, United States|Jacksonville Center for Clinical Research, Jacksonville, Florida, 32216, United States|Adult Medicine of Lake County, Mount Dora, Florida, 32757, United States|Endocrine Research Solutions, Inc., Roswell, Georgia, 30076, United States|Cedar Crosse Research Center, Chicago, Illinois, 60607, United States|Evanston Premier Healthcare Research LLC, Skokie, Illinois, 60077, United States|Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50265, United States|Anderson Medical Research, Fort Washington, Maryland, 20744, United States|StudyMetrix Research, Saint Peters, Missouri, 63303, United States|Mercury Street Medical Group, PLLC, Butte, Montana, 59701, United States|Hassman Research Institute, Berlin, New Jersey, 08009, United States|Premier Research, Trenton, New Jersey, 08611, United States|Medication Management, Greensboro, North Carolina, 27405, United States|Meridian Clinical Research, LLC, Cincinnati, Ohio, 45219, United States|Alliance for Multispecialty Research, LLC, Norman, Oklahoma, 73069, United States|Heritage Valley Multispecialty Group, Inc, Beaver, Pennsylvania, 15009, United States|Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18), Pittsburgh, Pennsylvania, 15236, United States|Preferred Primary Care Physicians, Uniontown, Pennsylvania, 15401, United States|Velocity Clinical Research, Providence, East Greenwich, Rhode Island, 02818, United States|HealthStar Physicians, P.C., Morristown, Tennessee, 37813, United States|Healthstar Physicians, Morristown, Tennessee, 37813, United States|Elligo Clinical Research Center, Austin, Texas, 78738, United States|Velocity Clinical Research, Dallas, Dallas, Texas, 75230, United States|UT Southwestern Medical Center, Dallas, Texas, 75390, United States|Medical Colleagues of Texas, LLP, Katy, Texas, 77450, United States|Tapia Internal Medicine Clinic, Paris, Texas, 75462, United States|Northeast Clinical Research of San Antonio, San Antonio, Texas, 78233, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Sugar Lakes Family Practice, Sugar Land, Texas, 77479, United States|Chrysalis Clinical Research, Saint George, Utah, 84790, United States|Southwest Internal Medicine, Saint George, Utah, 84790, United States|Manassas Clinical Research Center, Manassas, Virginia, 20110, United States|Medical Centre "Asklepiy", Dupnitsa, Kyustendil, 2600, Bulgaria|Diagnostic Consultative Center Aleksandrovska, Sofia, Sofia (stolitsa), 1431, Bulgaria|MHAT Botevgrad, Botevgrad, Sofia, 2140, Bulgaria|Medical Center Zdrave 1, Kozloduy, Vratsa, 3320, Bulgaria|"Prevencia - 2000 - Medical Center for Prehospital Medical Care" OOD, Stara Zagora, 6000, Bulgaria|Dr. M.B. Jones Inc., Victoria, British Columbia, V8V 4A1, Canada|G A Research Associates, Moncton, New Brunswick, E1G 1A7, Canada|Aggarwal and Associates Limited, Brampton, Ontario, L6T 0G1, Canada|Dawson Clinical Research, Guelph, Ontario, N1H 1B1, Canada|Milestone Research Inc., London, Ontario, N5W 6A2, Canada|Bluewater Clinical Research Group Inc., Sarnia, Ontario, N7T 4X3, Canada|LMC Clinical Research Inc. (Bayview), Toronto, Ontario, M4G 3E8, Canada|Manna Research Mirabel, Mirabel, Quebec, J7J 2K8, Canada|Diex Recherche Victoriavile Inc., Victoriaville, Quebec, G6P 6P6, Canada|Diex Recherche Quebec Inc., Quebec, G1V 4T3, Canada|Centre de Recherche Saint-Louis, Quebec, G1W 4R4, Canada|MUDr. Alena Vachova, Ceske Budejovice, Jihočeský KRAJ, 37011, Czechia|EDUMED s.r.o., Broumov, Kralovehradecky KRAY, 550 01, Czechia|Kardiologicka a Angiologicka Ambulance, Ostrava, Ostrava Město, 700 30, Czechia|Clinical Trials Service s.r.o., Uherské Hradiště, Zlínský KRAJ, 686 01, Czechia|Agentura Science Pro, Olomouc, 779 00, Czechia|Private Practice - Dr. Tomáš Brychta, Olomouc, 779 00, Czechia|EUC Klinika Praha, Prague, 150 00, Czechia|Clinical Trials Service s.r.o., Uherske Hradiste, Czechia|Belinus Orvosi és Számitástechnikai Bt, Debrecen, Hajdú-bihar, 4025, Hungary|Borbánya Praxis, Nyíregyháza, Borbánya, Szabolcs-szatmár-bereg, 4405, Hungary|CLINFAN Szolgáltató Kft, Szekszárd, Tolna, 7100, Hungary|DRC Gyógyszervizsgáló Központ, Balatonfüred, Veszprém, 8230, Hungary|ClinDiab Kft., Budapest, 1089, Hungary|Debreceni Egyetem Klinikai Kozpont, Debrecen, 04032, Hungary|Debreceni Egyetem Klinikai Kozpont, Debrecen, 4032, Hungary|Nakakinen clinic, Naka, Ibaraki, 311-0113, Japan|Yokohama Minoru Clinic, Yokohama, Kanagawa, 232-0064, Japan|Shiraiwa Medical Clinic, Kashiwara, Osaka, 582-0005, Japan|Medical Corporation Heishinkai OCROM Clinic, Suita-shi, Osaka, 565-0853, Japan|Seiwa Clinic, Adachi-ku, Tokyo, 120-0011, Japan|Seiwa Clinic, Adachi-ku, Tokyo, 123-0845, Japan|Tokyo-Eki Center-building Clinic, Chuo-ku, Tokyo, 103-0027, Japan|Medical Corporation Chiseikai Tokyo Center Clinic, Chuo-ku, Tokyo, 103-0028, Japan|Fukuwa Clinic, Chuo-ku, Tokyo, 104-0031, Japan|Medical Corporation Heishinkai ToCROM Clinic, Shinjuku-ku, Tokyo, 160-0008, Japan|Yokohama Minoru Clinic, Yokohama, 232-0064, Japan|KO-MED Centra Kliniczne Pulawy, Pulawy, Lubelskie, 24-100, Poland|Oświęcimskie Centrum Badań Klinicznych, Oświęcim, Małopolskie, 32-600, Poland|Zdrowie Osteo-Medic, Bialystok, Podlaskie, 15-351, Poland|Centrum Badan Klinicznych PI-House sp. z o.o., Gdansk, Pomorskie, 80-546, Poland|Centrum Zdrowia Metabolicznego Pawel Bogdanski, Poznan, 60-589, Poland|Gabinet Lekarski Małgorzata Jadwiga Saryusz-Wolska, Łódź, 90-132, Poland|NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki, Ruda Slaska, Śląskie, 41-709, Poland|Latin Clinical Trial Center, San Juan, 00909, Puerto Rico|GCM Medical Group, PSC - Hato Rey Site, San Juan, 00917, Puerto Rico
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