2. OBJECTIVE
The main objective of the study is to determine the number of patients ? 65 years who have been vaccinated for influenza stratified by different types of vaccine, selected from the population that has been visited at their referral hospital at least once and therefore have minimal basic data set (?CMBD?: the minimum basic data set is a population registry that collects information about problems treated in health centers in Catalonia. It is a valid and comprehensive data bank on morbidity and healthcare activity, compiled from information provided by all healthcare centers in Cataloni).
3. SAMPLE SIZE
Patients ? 65 years who have a medical history at the referral hospital (patients with CMBD) are selected from the total population contained in SIDIAP database. From these we extract the patients vaccinated by influenza stratified by types of vaccines (MF59 adjuvanted versus others), and the number of patients with influenza diagnosis. Patients (n and mean age) who have been hospitalized for influenza episodes are also counted (figure 1).

Exenatide is a new treatment for type 2 diabetes mellitus (T2DM) in adult patients and is used in combination with other glucose-lowering drugs (GLDs) when previous treatment regimens have resulted in inadequate responses. It is available as a twice-daily injectable product (Byetta®) and a once-weekly injectable product (Bydureon®). Byetta® was approved by the European Medicine Agency (EMA) in 2006, while Bydureon® was approved by the EMA in 2011. Both Byetta® and Bydureon® were subsequently launched in Spain.
As part of risk assessment of new drugs, EMA requires that the marketing authorisation holder of exenatide, Astra Zeneca, performs a post-authorisation safety (PAS) study, to assess the incidence of pancreatic cancer and thyroid neoplasm among patients with T2DM who initiated exenatide, twice-daily or once-weekly formulations, as compared with those who initiated other GLDs.
This data request is a part of a feasibility study for the required PAS study, to assess in which countries the required study could be conducted. The feasibility study includes several European countries, including Spain. Through this aggregate data request, we aim to determine in the SIDIAP database from Spain the total number of individuals in three different drug user groups and a comparison group, depending on the stepwise addition of specific inclusion or exclusion criteria. Therefore, it is important that the total number of individuals per year is obtained in the specified order given in Tables 1-4 (below), such that the number of individuals who fulfil criteria 1 are then examined to determine if they fulfil criteria 2, and so on. We also hope to estimate the length of exposure to the drug of interest to be able to estimate average follow-up time in power calculations (Table 5).

Objectius: Càlcul de la n de pacients tributaris a rebre tractament amb lesinurad.
La hiperuricèmia asimptomàtica no es tracta, només la gota (clínica o demostració de cristalls en teixits). Així, els pacients ja tractats amb un hipouricemiant en monoteràpia (al·lopurinol o febuxostat) no controlats són els pacients candidats. L?objectiu d?uricèmia amb més consens és =6 mg/dl tot i que es recomana de 5 mg/dl en certes situacions. Per tant seria d?utilitat conèixer el nombre de pacients tractats en monoteràpia mal controlats