Definition of Terms - Mundipharma Research

1 Name of Company: The company that sponsored the trial either Mundipharma Research GmbH & Co. KG or Mundipharma Research Ltd Definition of Terms : Name of Finished Product: This is the name of the study drug that is being tested (generic name) Name of Active Ingredient: This lists the names of the active ingredient (s) of the product being tested Title of the Study: This is the full title of the study Investigator(s)/Centre(s): This is a summary of the numbers of sites in each country which participated Publication Reference: This is a reference to where this information has been published (if available) Study Dates: This is the date the first subject was entered into the study, (First Patient, First Visit) to the date the last subject completed the study, (Last Patient, Last Visit) Study Status: The status of the study currently Phase of Development.

2 The phase of the clinical trial, see aboveObjectives: A summary of the main objective (s) for definitions Methodology: A summary of the planned methods used to achieve the objective (s) Number of Subjects: This is the number of subjects that were planned compared to the number of subjects that were actually recruited (randomised) for each section of the study Inclusion/Exclusion Criteria: This is a summary of the main criteria for including or excluding a subject in this clinical trial Test Treatment, Dose and Mode of Administration: The drug under investigation, the dose (s) used in the study and the way it was taken by the subjects ( orally) Reference Treatment, Dose and Mode of Administration: The comparator drug used in the study, the dose (s) and the way it was taken by the subjects ( orally) Duration of Treatment: The length of each period of the trial Treatment Schedule: Exact details of study requirements by each visit/period Criteria for Evaluation: The main criteria that were used for evaluation during the trial Statistical Methods: This is a summary of the statistical methods used in the trial Results: This is the summary of the main results of the trial Conclusions: The main conclusions of the trial Date of the report: The date the report was finalised Glossary of Abbreviations.

3 ADR Adverse Drug Reaction AE Adverse Event ANOVA Analysis of variance BFI Bowel Function Index BM Bowel Movement BPI-SF Brief Pain Inventory Short Form CI Confidence interval CRO Contract Research Organisation CSBM-NSND Complete Spontaneous Bowel Movement Non Straining Non Diarrhoea CSR clinical Study Report ECG Electrocardiogram EU European Union FPFV First Patient First Visit GCP Good clinical Practice hCG Human chorionic gonadotropin IBS Irritable Bowel Syndrome ICH International Conference for Harmonisation IEC Independent Ethics Committee IR Immediate Release IRB Institutional Review Board IVRS Interactive Voice Response System LKP Leiter der Klinischen Pr fung LOCF Last observation carried forward LPLV Last Patient Last Visit mg Milligrams MMRM Mixed-Model Repeated Measures N The number of study participants in the population of interest n The number of study participants in a sample of the population of interest NAS Numerical Analogue Scale OXN Oxycodone/Naloxone PR OXY Oxycodone PR p Probability value PACOI Patient Assessment of Opioid Induced Constipation PAC-SYM Patient Assessment of Constipation Symptoms PGIC Patient s Global Impression of Change PK Pharmacokinetics PP Per Protocol PR Prolonged Release q12h Every 12 hours SAE Serious adverse event SBM Spontaneous Bowel Movement SD Standard deviation SF-36 Short Form-36 SOPs Standard operating procedures SOWS Symptoms of Opioid Withdrawal Scale SPC Summary of Product Characteristics TSQM Treatment Satisfaction Questionnaire for Medication WHO World Health Organisation