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INTRODUCTION: This report describes the outcome of the Work Package 2 (WP 2) “Methodology and FOT Design” within the project SeMiFOT. This work package was divided into four tasks: “Identification of function and vehicles”, “Definition of objectives, hypotheses, and performance indicators for each function”, “Specification of experimental procedures” and “FOT process structuring and integration into product development”. It was, however, decided to move the fourth task to Work Package 5 “Evaluation of Methodology”, therefore it is not dealt with in the present report. The task reports attached to this report were inserted on 2008-10-31, changes after that date are not reported and the task reports may differ from the actual turnout. The reader is referred to the SeMiFOT Final Report for a description of the actual turnout. Early on, it was identified that it was necessary to apply for an ethical approval when running a study such as SeMiFOT, and, even though that was not originally identified as a specific task within WP 2, it was considered most appropriate that a majority of that work was carried out here. Therefore a chapter on ethics is included within this report. The overall aim of WP 2 is to further develop the Naturalistic FOT method into a powerful tool for (a) accident research, and (b) evaluation of traffic safety, traffic efficiency, and usage & acceptance, and (c) countermeasures innovation and development. It will do so by further developing the methodology from the state-of-the-art at UMTRI1, within FESTA2, and TSS FOT3. The objective of this report is to give an overview of how the project group has worked towards the aim of WP 2, report on the decisions that has been made and finally discuss lessons learned from this methodology project. Task 2.1 “Identification of functions and vehicles” was led by AB Volvo. It covered the first stages of the project, during which it was defined how many and which vehicles were to be used by each OEM. During Task 2.2 “Definition of objectives, hypotheses, and performance indicators for each function”, which was led by SAFER, research questions and related hypotheses were selected and appropriate performance indicators were determined. Task 2.3 “Specification of experimental procedures” was led by VTI. In this Task, based on the given restrictions different experimental designs were suggested for testing different functions, and an experimental protocol was determined. As mentioned above Task 2.4 (Specification of experimental procedures and FOT process structuring and integration into product development), led by VCC, was moved to WP5, because it was decided that the content could be dealt with better at a later stage when some results would be present.