Participants may not have any of the following cardiac criteria:\r\n* Mean resting corrected QT interval (QTc) > msec obtained from electrocardiograms (ECGs) using the screening clinic ECG machine-derived QTc value\r\n* No history of QT prolongation associated with other medications that required discontinuation of that medication\r\n* Patient must not be receiving any concomitant medications that are known to be associated with Torsades de Pointes\r\n* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG eg, complete left bundle branch block, third degree heart block, second degree heart block, any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under years of age in first degree relatives or any concomitant medication known to prolong the QT interval\r\n* Symptomatic heart failure New York Heart Association (NYHA) grade II-IV Any of the following cardiac criteria:\r\n* Resting corrected QT interval (QTc) > msec obtained from electrocardiogram (ECG)\r\n* Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG) eg, complete left bundle branch block, third degree heart block\r\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under years of age or any concomitant medication known to prolong the QT interval\r\n* Experience of any of the following procedures or conditions in the preceding months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) grade >= \r\n* Uncontrolled hypotension systolic blood pressure (BP) < mmHg and/or diastolic BP < mmHg\r\n* Left ventricular ejection fraction (LVEF) below lower limit of normal for site Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiography (ECG), e.g. complete left bundle branch block, third-degree heart block, second-degree heart block, QT interval corrected by Fridericias formula (QTcF) of >= ms in males or >= ms in females Significant medical history or unstable medical comorbidities, including:\r\n* Heart disease including congestive heart failure (New York Heart Association [NYHA] grade II or greater); unstable angina; prior myocardial infarction (non-ST elevation myocardial infarction [NSTEMI] or ST elevation myocardial infarction [STEMI]) within months prior to study enrollment; hypertension with a systolic blood pressure of > mm Hg or diastolic blood pressure of > mm Hg while on antihypertensive medication\r\n* Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG), e.g. complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval > msec, mean resting corrected QT value (QTc) of > msec\r\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under years of age in first degree relatives, or any concomitant medication known to the prolong the QT interval that a patient is unable to stop\r\n* Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease\r\n* Active bleeding diatheses, which in the investigators opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol\r\n* Active infection or ongoing antiviral medication for viral infections including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV); screening for chronic conditions is not required; HIV-positive participants on combination antiretroviral therapy are ineligible Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval >msec). Clinically important abnormalities in rhythm, conduction, or morphology of resting ECGs, e.g., complete left bundle branch block, third degree heart block Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECGs, e.g., complete left bundle branch block, third degree heart block Any of the following cardiac abnormalities or history:\r\n* Mean resting corrected QT interval (QTc) > msec, obtained from electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value\r\n* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block\r\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under years of age in first degree relatives or any concomitant medication known to prolong the QT interval Any clinically important abnormalities in rhythm, conduction or morphology of a resting ECG, e.g., complete left bundle branch block, third degree heart block, that in the opinion of the Investigator render the patient unsuitable for participation in the study Any of the following cardiac criteria: \r\n* Mean resting corrected QT interval (QTc using Fridericia's formula) > msec;\r\n* Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG) e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval > msec;\r\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under years of age in first degree relatives or any concomitant medication known to prolong the QT interval Any of the following cardiac criteria:\r\n* Mean resting corrected QT interval (QTc using Fredericas formula [QTcF]) > msec\r\n* Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG) (e.g., complete left bundle branch block, third degree heart block, second degree heart block)\r\n* Congenital long QT syndrome or family history of long QT syndrome Has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG, eg, complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval > milliseconds (ms). Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block) Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting Electrocardiograms, e.g., complete left bundle branch block, third degree heart block Any of the following cardiac criteria\r\n* Resting corrected QT interval (QTc using Fridericias formula) > msec\r\n* Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiograph (ECG) (e.g., complete left bundle branch block, third degree heart block, second degree heart block)\r\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under years of age in first degree relatives or any concomitant medication known to prolong the QT interval \r\n** Symptomatic congestive heart failure or left ventricular ejection fraction (LVEF) < % Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG. Any of the following cardiac criteria:\r\n* Mean resting corrected QT interval (Fridericia's correction formula [QTcF]) > ms ms obtained from electrocardiograms (ECGs), using the screening clinic ECG machine derived corrected QT (QTc) value\r\n* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block)\r\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under years of age in first degree relatives or any concomitant medication known to prolong the QT interval Abnormalities in rhythm, conduction or morphology of resting -lead ECG Any clinically relevant abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval > msec). Any of the following cardiac criteria: Mean resting QT interval corrected for heart rate (QTc) more than msec, obtained from ECGs, using the screening clinic ECG machine derived QTc value. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under years of age in first degree relatives or any concomitant medication known to prolong the QT interval Patients must not have a mean resting corrected QT interval (QTc) > msec obtained from consecutive electrocardiograms (ECGs); performed within days prior to sub-study registration; patients must not have any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block); patients must not have any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under years of age Patients must not have a mean resting corrected QT interval (QTc) > msec obtained from consecutive electrocardiograms (ECGs); performed within days prior to Step re-registration; patients must not have any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block); patients must not have any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under years of age Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiography (ECG) (e.g., complete left bundle branch block, third degree heart block, second degree heart block) Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third degree heart block Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG. Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiograms, e.g. complete left bundle branch block, third degree heart block, second degree heart block, PR interval > msec. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG eg, complete left bundle branch block, third degree heart block Has any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG), eg, complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval > milliseconds (ms) Cardiac criteria such as unstable angina, myocardial infarction within months of screening, NY Heart Association Class or heart failure, QTc greater than msec, congenital long Qt syndrome, symptomatic orthostatic hypotension within months of screening, uncontrolled hypertension, or clinically important abnormalities in heart rhythm, conduction, morphology of resting ECG