In the provided safety database for an anti-hypertensive drug, which long-term ICH data requirement has not been met?

The requirement to have safety data from 100 patients for 12 months is essential for long-term evaluations of an anti-hypertensive drug under the International Council for Harmonisation (ICH) guidelines. This duration allows for a thorough assessment of the drug's safety profile over an extended period, particularly considering how patients may respond to the medication differently over time and the potential for long-term adverse effects that may not be immediately apparent in shorter studies.

Within the context of comparing the long-term requirements, options A, B, and D do not meet the ICH standards for the duration and patient numbers specified for long-term safety evaluation. In particular, while options A and B specify larger patient populations, they do not fulfill the 12-month requirement that is critical for long-term therapies. Option D, despite having a larger patient cohort, only covers 3 months, which is insufficient for long-term safety data.

Thus, the answer reflects a failure to meet the long-term ICH data requirement of having 100 patients recorded over a 12-month period, ensuring that the safety profile is adequately understood for the drug's use in the population.