- Detection of postoperative pain related to urinary drainage by numeric rating scale (NRS); time frame: once a day, first 7 days after the surgery<br/>- Recording of complications; time frame: within the 4 weeks after surgery<br/>- Urine status measured by flow cytometry; time frame: within the day 2 or day 5 after the surgery<br/>- Residual urine measured by bladder scan in ml; time frame: 3 times within the day 2 or day 5 after the surgery<br/>
- Reduction of key side effects; time frame: up to 7 months; Key side effects are defined as capillary leak syndrome and cytokine release syndrome. Reduction is defined by at least 1 grade or score point or day less.<br/>- Maximum of antibody-related pain; time frame: up to 5 months; Neuralgia (with assessment of pain duration by days requiring morphine and maximum grade of pain scores during first 2 antibody cycles) will compared between both arms.<br/>- Comparative pharmacokinetics; time frame: up to 2 months; Maximum plasma concentration of the antibody assessed during the first 2 months of treatment.<br/>
- Delivery Rate and Live Birth Rate; time frame: nearly 9 month after treatment start<br/>- Implantation Rate; time frame: Four to five weeks after oocytes retrieval; Implantation rate was defined as the mean of the total number of gestational sacs seen divided by the total number of embryos transferred. Values are reported as a percentage.<br/>
Incidence of procedural embolism, non sustained ventricular tachycardia, asystole, bradycardia
- Change in Number of Micturitions; time frame: Baseline, Week 2, Week 6, Week 12; Mean number of micturitions measured over a 7 day diary prior to each visit. Micturation is defined as urinating into the toilet.<br/>- Change in Number of Nocturia Episodes; time frame: Baseline, Week 12; Mean number of nocturia episodes measured over a 7 day diary prior to each visit. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep.<br/>- Maximum Cystometric Capacity (MCC) by Urodynamic Measurements; time frame: Baseline, Week 12; Maximum Cystometric Capacity (maximum volume that the bladder can hold) measured in mean milliliters<br/>- Incontinence Quality of Life Instrument (I-QOL); time frame: Baseline, Week 2, Week 6, Week 12; Measured on 3 domains; a 5-point scale (1-5) for each domain. Sum of the domain scores is normalized to a scale of 0-100 (100 = no impact of incontinence on daily activities, 0 = maximum impact of incontinence on daily activities). Mean scores presented.<br/>
- Overall Survival is measured as the time interval from start of Nexavar therapy to the date of death, due to any reason.; time frame: up to 54 months<br/>- Time to progression is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression.; time frame: up to 54 months<br/>- Progression free survival is measured as the time interval from the start of Nexavar treatment to diagnosed (radiological or clinical) progression or death, whichever comes first.; time frame: up to 54 months<br/>- Time to treatment failure is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression or permanent discontinuation due to toxicity.; time frame: up to 54 months<br/>- Duration of Nexavar treatment is measured as the time interval from start of Nexavar therapy to the date of permanent discontinuation of Nexavar therapy (regardless of the reason for discontinuation).; time frame: up to 54 months<br/>- Tumor status at different visits will be evaluated according to radiological or clinical evaluation. The best overall response will be analyzed providing absolute and relative frequencies of the tumor status categories.; time frame: up to 54 months<br/>- Further possible prognostic factors will be evaluated.; time frame: up to 54 months<br/>- Safety variables will be summarized using descriptive statistics based on adverse events collection.; time frame: up to 54 months<br/>
- Endometriosis-associated pain; time frame: The day before laparoscopy is performed; Outcome measure is measured by visual analogue scale<br/>- Endometriosis-associated pain; time frame: One year after completion of endometriosis treatment; Outcome measure is measured by visual analogue scale<br/>
- Proportion of patients with CR in delayed and overall phases.; time frame: from >24 to 120 hours  (delayed phase) after T0; 0 to 120 hours (overall period) after T0; 0 to 24 hours after T0 (acute phase); For each period during first cycle: Proportion of patients without vomiting, without emetic episodes, without antiemetic rescue medication and without nausea (patients aged ≥ 6 years)<br/>
- Incidence of Loco-regional relapse; time frame: assessment after patient has completed follow-up<br/>- Disease-free survival; time frame: time from start of surgery to the first evidence of loco-regional or distant tumor relapse or death<br/>- Progression-free survival; time frame: from start of surgery to the first observation of disease progression or death<br/>- Overall survival; time frame: censored at the time of last documented efficacy<br/>- The rate of patients with secondary primary neoplasm; time frame: assessment after patient has completed follow-up<br/>- The incidence of late toxicity; time frame: beyond 90 days after start of radiation therapy<br/>
- MMR rate; time frame: 5 years after first dose; To compare the efficacy of ponatinib with imatinib, as measured by MMR rate, at 5 years<br/>- <10% BCR-ABL^IS rate; time frame: 3 months after first dose; To compare the proportion of patients achieving a ratio of <10% BCR-ABL to ABL transcript levels at 3 months, as measured by the international scale (<10% BCR-ABL^IS), in patients administered ponatinib versus those administered imatinib<br/>- Complete cytogenetic response (CCyR) rate; time frame: 12 months after first dose; To compare, according to treatment with ponatinib versus imatinib, the CCyR rate at 12 months<br/>- Progression-free survival; time frame: Up to 8 years after the last patient's first dose; To compare, according to treatment with ponatinib versus imatinib, progression-free survival<br/>- Overall survival; time frame: Up to 8 years after the last patient's first dose; To compare, according to treatment with ponatinib versus imatinib, overall survival<br/>
- Biomarkers in PXE; time frame: 1 day (first visit); Potential systemic biomarkers are investigated by collecting blood samples of PXE patients<br/>
- Progression-free survival; time frame: 36 months<br/>- Objective Response Rate; time frame: 36 months<br/>- Disease control rate; time frame: 36 months<br/>- Duration of response; time frame: 36 months<br/>- Symptom improvement; time frame: 36 months; Symptom improvement will be evaluated based on patient responses to quality of life questionnaires.<br/>- Number of Participants with Adverse Events as a Measure of Safety and Tolerability; time frame: 36 months<br/>- Exploratory biomarker analyses; time frame: 36 months; Exploratory biomarker analyses will assess correlation between biomarkers and clinical outcome.<br/>- Emergence of metastatic lesions; time frame: 36 months<br/>
- Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria; time frame: Up to 12 months; The time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group (PSAWG) criteria, namely, a PSA level of at least 5 ng/ml that has risen on at least 2 successive occasions, at least 2 weeks apart.<br/>- Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%; time frame: Up to 12 months; A prostate-specific antigen (PSA) response was defined as a >=50% decline from baseline.<br/>- Radiographic Progression-free Survival; time frame: Up to 11 months; Radiographic progression-free survival is based on imaging studies according to modified Response Evaluation Criteria in Solid Tumors (RECIST): baseline lymph node size must be >=2.0 cm to be considered a target lesion; progression on bone scans with >=2 new lesions not consistent with tumor flare, confirmed on a second scan >=6 weeks later that shows >=1 additional new lesion.<br/>
- Pain; time frame: every 30 days<br/>- Change in prostate specific antigen; time frame: every 30 days<br/>- Quality of Life; time frame: every 30 days<br/>- Correlation between pain and bone turnover; time frame: at end of study<br/>- Correlation between bone complications and bone turnover; time frame: end of study<br/>
- Obtain additional estimates of the efficacy of study drug vs. physician's choice of selected chemotherapies in terms of overall survival, objective response rate, duration of response and disease control rate.; time frame: 6 years<br/>- Characterize the safety profile of the study drug vs. physician's choice of selected chemotherapies in terms of adverse events and clinical laboratory tests.; time frame: 3 years<br/>- Assess the effect on global health status of study drug vs. physician's choice of selected chemotherapies in terms of quality-of-life questionnaires.; time frame: 3 years<br/>- Characterize the plasma pharmacokinetics (PK) of study drug in terms of plasma concentration-time profiles and model-based PK parameters.; time frame: 3 years<br/>
- Biomarkers in PXE; time frame: 1 day (first visit); Potential systemic biomarkers are investigated by collecting blood samples of PXE patients<br/>
- Maintenance in hemoglobin target range (10.0 to 12.0 g/dL); time frame: Up to 16 weeks<br/>- Change in hemoglobin level; time frame: Baseline up to 16 weeks<br/>- Number of patients with hemoglobin levels outside the target range; time frame: Week 12 to 16<br/>- Dose level in the evaluation period; time frame: Week 12 to 16<br/>- Duration of exposure on each dose level; time frame: Up to 16 weeks<br/>- Number of subjects requiring titration of dose; time frame: Up to 16 weeks<br/>- Number of participants with serious adverse events as a measure of safety and tolerability; time frame: Up to 16 weeks<br/>
- Rate of adverse events; time frame: Approximately 67 Days<br/>- Severity of adverse events; time frame: Approximately 67 Days<br/>- Safety laboratory parameters; time frame: Approximately 67 Days<br/>- Vital signs; time frame: Approximately 67 Days<br/>- Electrocardiogram; time frame: Approximately 67 Days<br/>- Physical exam; time frame: Approximately 67 Days<br/>
- Time to relapse from inclusion up to 3 years; time frame: Time between inclusion and date of relapse or after 36 months, whichever comes first.<br/>- Quality of life at baseline, 12 and 24 months post inclusion; time frame: From inclusion (baseline) until relapse or death from any cause or at 12 and 24 months, whichever comes first.<br/>- In RICT patients only: Safety and feasibility of the procedure from inclusion to 3 years; time frame: Non-relapse mortality (NRM) and overall survival at two occasions up to 36 months after inclusion.<br/>- In RICT patients: Incidence & severity of acute and chronic GvHD from transplantation to three years after inclusion; time frame: From transplantation until end of study, up to 36 months after inclusion.<br/>- In RICT patients: Rate of complete or partial chimerism from transplant to 3 months; time frame: At Day +100 post Tx<br/>
- acute toxicity; time frame: 3 months after treatment; measured from the first day of treatment<br/>- local recurrence free survival; time frame: 24 months after therapy; measured from the first day of treatment<br/>- overall survival; time frame: 24 months after therapy; measured from the first day of treatment<br/>- quality of life; time frame: 24 months after therapy; measured from the first day of treatment<br/>
To determine the pharmacokinetics of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects.<br/>To quantify the mobilization of HSCs in peripheral blood after repeated doses of NOX-A12 alone, of filgrastim alone and after the combination of NOX-A12 with filgrastim.<br/>
1. neurological status (motor function, sensation) of the affected limb after 4 weeks<br/>2. frequency of systemic complications in both groups <br/>3. tolerance of the reperfusion solution<br/>4. mortality after 6 and 12 months
- Progression Free Survival (PFS); time frame: up to 6 years<br/>
- Adverse events; time frame: Daily assessment up to 7 days from informed consent; Number of adverse events reported by the patients or observed by the investigator will be recorded. Onset, end date, severity, causal relationship, outcome and measures taken will be summarized. Discontinuations and serious adverse events will be listed and narrative summaries will be provided.<br/>- Laboratory abnormalities; time frame: Screening, Day -1, Day 2, Day 3, and Day 7; The number and severity of blood chemistry and hematology findings will be summarized descriptively and compared to baseline.<br/>
- Dosage/schedule: Initiation/duration/modification/discontinuation of Perjeta administration; time frame: approximately 7.5 years<br/>- Clinical/demographic patients characteristics at initiation of treatment; time frame: approximately 7.5 years<br/>- Safety: Incidence of adverse events; time frame: approximately 7.5 years<br/>- Patient reported outcome: Quality of life (FACT B questionnaire); time frame: approximately 7.5 years<br/>
Investigation of the use of the tonsils, as the only available secondary lymphoid organ, for the determination of the immune status of patients with sepsis
Overall survival within 4 years.
Exploratory data analysis of the following parameters: <br/>- Height of the coronary arteries,  sinus of valsalva diameter, sinutubular junction diameter, <br/>(the measurement of these parameters using CT and TEE are performed before intervention).<br/>- angulation angle (the angle is measured by using CT before intervention and by fusion periinterventionally).
Efficiency endpoint of proportion of patients in whom coronary angiography is performed copeptin vs. control arm.<br/>Proportion of patients requiring PCI due to their findings in cardiac catheterization copeptin vs. control arm. (Assessment of Copeptin as a rule-in marker)<br/>Further secondary endpoints evaluate efficacy, safety, cost effectiveness and patient satisfaction of  the new process including length of stay in the hospital.<br/>All-cause death, survived sudden cardiac arrest, myocardial infarction, re-hospitalisation for acute coronary syndrome, acute unplanned PCI, coronary artery bypass grafting (CABG) and documented life-threatening arrhythmias (VF, VT, AV-block III) at 30 and 90 days.
Possible, respectively missed indications for pre-hospital TXA application
At the second assessment point, the nursing staff will evaluate the acceptance and applicability of the intervention using a self-developed questionnaire
Derivation of diagnostic parameters. Comparison of derived parameters with established methods.
morbidity: serious adverse drug reaction during the observation period of 9 month. Number of hospitailzation due to serious adverse drug reaction. Number of specialist's referral due do problems with the medication. Number of change in medication during the observation period of 9 month.<br/>mortality: number of death during the observation period of 9 month.<br/>Effectiveness: qualtiy of life (SF-36; 3,6, and 9 month after start of the study). Cost of medication and of potantil additional doctor’s visit. cost-benefit analysis (that takes mobidity and mortality into account)<br/>
radiological proof of a change in the calcification in the postoperative x-ray
n/a
Colour stability, soft tissue reaction, clinical handling, accuracy of fit, outer shape, plaque accumulation, adhesion to the tooth stump and patients' opinion of the temporary restorations being made of Protemp 4 in comparison to the data of the  temporary restorations being made of Luxatemp® Automix Plus (Reference data)
Reduction of on demand medication during follow-up (day 4-7). On demand opioid drug use will be converted into an oral morphine equivalent (OME) for ease of comparison (Baseline, Therapy, Follow-up).
Late performance success defined as: successful closure of the defect without major complication (surgical reintervention, device embolization, moderate or large residual shunt, new AV block II or III° ) 6 month after the procedure
Current antiretroviral therapy, remaining options. Virological and immunological situation. Physical and mental health of the patients. Adherence and treatment satisfaction with current antiretroviral therapy (evaluated by questionnaires)
same as primary end point but in relation to German average
Proportion of patients with a vision acuity loss of fewer than 15 letters at month 12 (visit 13) compared with baseline<br/>- - - Proportion of patients with a vision acuity loss of more than 15 letters at month 12 (visit 13) compared with baseline (visual acuity measured by ETDRS-charts)<br/>- - - Proportion of patients with a treatment-free interval of at least 3 months duration at any time point following visit 3 (at month 2)<br/>- - - Drop out rates<br/>- - - Rate of non-responders<br/>- - - Retinal lesions <br/>- - - Changes in retinal thickness from baseline at month 4 and 12 (visit 13) via Optical Coherence Tomography (OCT)<br/>- - - AEs<br/>- - - Quality of Life at visit 1 (before treatment) and visit 13 (month 12); questionnaire VFQ25.<br/><br/>
Prescribing and reporting behavior of outpatient doctors<br/>
Not applicable
Mortality
- Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Blinded Independent Central Imaging Review; time frame: Up to approximately 2 years<br/>- Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by Blinded Independent Central Imaging Review; time frame: Up to approximately 2 years<br/>- Number of Participants Who Experience an Adverse Event (AE); time frame: Up to approximately 39 months<br/>- Number of Participants Who Discontinue Study Drug Due to an AE; time frame: Up to approximately 39 months<br/>
Speed of analysis
isoflavone metabolites in body fluids
4 to 6 weeks prior surgery and 3 months after surgery the following endpoints will be evaluated:<br/>•Influence of patellar stabilization on patellofemoral kinematics, determined using MRI at 0,10,20,30° of flexion<br/>•Measure of cartilage compression,determined using MRI at 0,10,20,30° of flexion<br/>•Measure of cartialge relaxation times,determined using MRI at 0,10,20,30° of flexion<br/><br/>
- progression-free survival rate at 9 and 12 months; time frame: 9 and 12 months after study entry<br/>- median progression-free survival; time frame: 48 months<br/>- response rate; time frame: 48 months<br/>- duration of response; time frame: 48 months<br/>- toxicity; time frame: 48 months; number of patients with Adverse Events according to CTC-criteria<br/>- tolerability; time frame: 48 months; number of patients having adverse events and require interruptions and dose reductions of chemotherapy<br/>- overall survival; time frame: 48 months<br/>- time to treatment failure; time frame: 48 months<br/>- evaluation of the predictive and prognostic relevance of biomarkers; time frame: 48 months; collection of plasma samples at designated time points during treatment and measuring of angiogenic factors correlating with response rate and outcome<br/>
mechanisms of change of the training, measured by qualitative interviews with the trainers, the team and the team members. Analyzed by qualitative content analysis.
• Diagnostic performance regarding flat and papillary tumours<br/>• False-positive rate<br/>• To evaluate systemic absorption and pharmacokinetics (PK) of<br/>Hypericin after a single intravesical instillation of PVP-Hypericin in a<br/>sub-group of patients (N=15-20)<br/>• To assess the safety of PVP-Hypericin (data collection of adverse events)
secondary endpoint: inflammatory parameters and mediators in the blood)<br/>
At time point six months post training period<br/>-  TAP (Testbatterie für Aufmerksamkeit, test battery for attention) <br/>-  Berg Balance Test (BBT)<br/>-  Activity of Daily living (ADL) and Instrumental activity of daily living (IADL)<br/>-  Functional gait category (FAC)<br/>-  6min walking test (6mintest)<br/><br/>At the end of the training period<br/>- amount of total steps during the training period
- To assess the effect of 3% Polidocanol on pruritus induced by histamine (by VAS for 30 minutes)<br/>- To assess the effect of 3% Polidocanol on wheal development, flare development, and change in blood flow induced by Mucuna pruriens (cowhage). Wheal development will be assessed by measuring wheal diameter (mean of the largest diameter and the perpendicular diameter) and volumetry of the wheal using digital volumetric measurements 15 and 30 minutes after provocation. Flare will be measured in extent by measuring flare diameter (mean of the largest diameter and the perpendicular diameter) and in intensity using a mexameter 15 and 30 minutes after provocation. <br/>- To assess the effect of 3% Polidocanol on wheal development, flare development, and change in blood flow induced by histamine as described above<br/>
subjective rating together with speech intelligibility (using questionnaire HisQui19)
Good neurological outcome with 90-day mRS≤2 or 90-day NIHSS score improvement ≥10 from baseline<br/>Excellent neurological outcomes with 90-day mRS≤1<br/>Infarct volume at 30 (-/+ 6) hours (CT or MRI).<br/>Difference of infarct volume from infarct volume as predicted by pretreatment imaging<br/>Functional health status and quality of life 90 (±14) days after stroke (EQ-5D)<br/>For the endovascular treatment group successful recanalization will be defined as TICI 2b or 3.
Expiratory peak flow, measured by pneumotachography as mean for the duration of the experiment. Regional ventilation, measured by electrical impedance tomography as a mean for the duration of the experiment. Subjective perception, rated by the volunteer as forced choice (better/worse), directly after the experiment.
Operative morbidity and mortality
Furthermore, mental, social and physical activities carried out over the lifespan are recorded and their connection to cognition analyzed
Comparison of quantitative flow Ratio (QFR) and instantaneous wave-free Ratio (iFR) with fractional flow Ratio (FFR)<br/>- Sensitivity and specificity of QFR according to FFR: Proportion of patients with positive/negative QFR and positive/negative FFR resp. (true positives/negatives) <br/>-	Diagnostic performance of QFR in comparison to FFR reported as positive and negative likelihood ratio <br/>-	Diagnostic grey zone calculation. QFR limits for achieving 95% sensitivity and specificity in comparison to FFR<br/>-	Sensitivity and specificity of iFR according to FFR: Proportion of patients with positive/negative iFR and positive/negative FFR resp. (true positives/negatives)  <br/>-	Diagnostic performance of iFR in comparison to FFR reported as positive and negative likelihood ratio <br/>-	Diagnostic grey zone calculation. iFR limits for achieving 95% sensitivity and specificity in comparison to FFR <br/>•	Cost analysis<br/>-	Cost savings of removing secondary investigations by using QFR<br/>-	Cost savings of removing the need for Adenosine by using iFR. <br/>-	Evaluation of costs by excess/reduced need for stenting when iFR and FFR disagree<br/>•	Lesion characteristics<br/>-	Influence of  3D QCA characteristics (minimum luminal area (MLA), percentage area stenosis, lesion length, minimum luminal diameter (MLD) and percentage diameter stenosis) in the prediction of iFR -FFR disagreement. <br/>-	Influence of  lesion location in the prediction of iFR -FFR disagreement. <br/>-	Influence of  p20-DAC2 score in proximal and mid-LAD stenosis in the prediction of iFR -FFR disagreement. <br/><br/>
Pain during wound dressing after tumor excision with visual analog pain scale (VAS)<br/>scar quaulity (POSAS scar scale) 6-12 months after skin grafting
strength (MRC, grip strength), fitness (PFIT-s), ADL (Barthel-Index) directly before study therapy, directly after last study therapy unit and 3 weeks after the last examination<br/><br/>time till achiving indipendent sit to stand from a normal chair: daily measurement before start of study therapy until discharge
- Correlation of CT perfusion parameters at baseline as well as their relative changes after start of antiangiogenic therapy with response status according to RECIST 1.1; time frame: up to 3 years<br/>
Secondary endpoint are cognition, assessed by the Trail Making Test, walking performance in single-task and dual-task condition (counting backwards in steps of 3), assessed on a GAITRite mat,and the sit-to-stand performance, classified by the time needed, during exposure to 15°C and 25°C environment, each.
- Objective response rate (RECIST v1.1 criteria); time frame: one year; Time to progression (TTP) of a patient being defined as the time in months from start of the first therapy cycle until PD is observed<br/>- Objective response rate (RECIST v1.1 criteria); time frame: one year; Overall survival (OS) calculated from the day of study enrolment until the day of death<br/>- Objective response rate (RECIST v1.1 criteria); time frame: one year; Progression-free survival (PFS) calculated from the day of study enrolment until the day of progression/death<br/>- Safety; time frame: one year; Toxicity and tolerability<br/>- Quality of life (EORTC QLQ-C30); time frame: one year; Quality of life (EORTC QLQ-C30)<br/>- Translational research program; time frame: one year; Translational research within a tumour bank<br/>
Secondary outcome are total cortisol output i.e. AUCi
- Best response to chemotherapy, response rate to chemotherapy , duration of response, toxicities and quality of life; timepoints for assessments will be at end of study, at 1,5 + 4 + 8 +12 + 18 + 24 + 30 months and thereafter 6 monthly; time frame: Every 35 days during treatment phase, after 4, 8, 12, 18, 24 months during follow-up<br/>
Blood or plasma cortisol during the Trier Social Stress Test (Kirschbaum, Pirke, & Hellhammer, 1993) at baseline and at the post-measuring time (after 25 sessions cognitive therapy or a wait time of 4-6 month) respectively the 6-month-follow-up.
- participation rate<br/>- number of complications arising in the screening colonoscopies in the program<br/>- positive predictive value of iFOBT (immunological fecal occult blood test): frequency of true and false positive findings
- Change in local laboratory hemoglobin level from baseline; time frame: Baseline up to 12 weeks<br/>- Speed of change in hemoglobin level per unit time; time frame: Up to 16 weeks<br/>- Duration of treatment exposure; time frame: Up to 16 weeks<br/>- Number of participants with serious adverse events as a measure of safety and tolerability; time frame: Up to 16 weeks<br/>- Pharmacodynamics characterized by erythropoietin concentration; time frame: Several time points up to 16 weeks<br/>- Pharmacodynamics characterized by reticulocyte count; time frame: Several time points up to 16 weeks<br/>
- Overall survival (OS); time frame: 5 years<br/>- Incidence of adverse events and significant laboratory abnormalities; time frame: 4 years<br/>- Pharmacokinetics of AMG 386 (Cmax and Cmin); time frame: 1 year; pre-dose weeks 1, 7, 10, 19 and within 10 minutes post dose week 1, 7<br/>- Incidence of anti-AMG 386 antibody formation; time frame: 4 years; pre-dose weeks 1, 10, 19<br/>- Patient reported ovarian cancer-specific symptoms and health related quality of life; time frame: 4 years<br/>- Patient reported status as measured by the EuroQOL (EQ-5D); time frame: 4 years<br/>- AMG 386 exposure-response relationships for PFS and OS; time frame: 4 years<br/>- Correlation of serum biomarkers with measures of response; time frame: 4 years<br/>
1. To evaluate the efficacy of lenabasum compared to placebo in the treatment of SSc by assessing<br/>the change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI)<br/>score at Week 52<br/>2. To evaluate the efficacy of lenabasum compared to placebo in the treatment of SSc by assessing<br/>the American College of Rheumatology (ACR) Provisional Combined Response Index in<br/>diffuse cutaneous Systemic Sclerosis (CRISS) score at Week 52.<br/>3. To evaluate the efficacy of lenabasum compared to placebo in the treatment of SSc by assessing<br/>the change from baseline in the forced vital capacity (FVC) % predicted at Week 52.<br/>