Vulnerable population (a) Description of the vulnerable population. (b) Description of the specific informed consent process. (c) Description of the Ethics Committee specific responsibility. (d) Description of what medical care, if any, will be provided for subjects after the clinical investigation has been completed. 1.16 Suspension or premature termination of the clinical investigation (a) Criteria and arrangements for suspension or premature termination of the whole clinical investigation or of the clinical investigation in one or more investigation sites. (b) Criteria for access to and breaking the blinding or masking code in case of suspension or premature termination of the clinical investigation, if the clinical investigation involves a blinding or masking technique. (c) Requirements for subject follow-up. 1.17 Publication policy (a) Statement indicating whether the results of the clinical investigation will be submitted for publication. (b) Statement indicating the conditions under which the results of the clirical investigation will be offered for publication.