Table 1.

WHO minimal dataset: version issued in April 2005 (used as checklist in this study) [5] and revised version issued in February-March 2006[9]

	Item 2005	Revised Item 2006	Abridged Definition/Explanation*
1	Unique trial number	Primary Registry and Trial Identification number	Name of Primary Registry, and the unique ID number assigned by the Primary Registry to this trial.
2	Trial registration date	Date of Registration in Primary Registry	Date when trial was officially registered in the Primary Registry.
3	Secondary IDs	Secondary identification number(s)	Other identifying numbers and issuing authorities besides the Primary Registry, if any.
4	Funding source(s)	Source(s) of Monetary or Material Support	Major source(s) of monetary or material support for the trial (e.g., funding agency, foundation, company).
5	Primary sponsor	Primary Sponsor	The individual, organization, group or other legal person taking responsibility for securing the arrangements to initiate and/or manage a trial (including arrangements to ensure that the trial design meets appropriate standards and to ensure appropriate conduct and reporting).
6	Secondary sponsor(s)	Secondary Sponsor(s)	Additional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on responsibilities of sponsorship.
7	Responsible contact person	Contact for Public Queries	Email address, telephone number, or postal address of the contact who will respond to general queries, including information about current recruitment status
8	Research contact person	Contact for Scientific Queries	Email address, telephone number, or postal address, and affiliation of the person to contact for scientific queries about the trial.
9	Title of the study (brief title)	Public Title	Title intended for the lay public in easily understood language.
10	Official scientific title of the study	Scientific Title	Scientific title of the trial as it appears in the protocol submitted for funding and ethical review. Include trial acronym if available.
11	Research ethics review		Eliminated
		Countries of Recruitment	The countries from which participants will be, are intended to be, or have been recruited.
12	Condition	Health Condition(s) or Problem(s) Studied	Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer, medication error).
13	Intervention(s)	Intervention(s)	Enter the specific name of the intervention(s) and the comparator/control(s) being studied. Use the International Non-Proprietary Name if possible. If the intervention consists of several separate treatments, list them all. For each intervention, describe other intervention details as applicable (dose, duration, mode of administration, etc).
14	Key inclusion and exclusion criteria	Key Inclusion and exclusion criteria	Inclusion and exclusion criteria for participant selection, including age and sex.
15	Study type	Study Type	A single arm trial is one in which all participants are given the same intervention. A trial is "randomized" if participants are assigned to intervention groups using a method based on chance.
16	Anticipated trial start date	Date of First Enrollment	Anticipated or actual date of enrollment of the first participant.
17	Target sample size	Target Sample Size	Number of participants that this trial plans to enroll.
18	Recruitment status	Recruitment Status	Recruitment status of this trial (e.g., pending, active, temporary halt, closed).
19	Primary outcome	Primary Outcome(s)	Outcomes are events, variables, or experiences that are measured because it is believed that they may be influenced by the intervention. The Primary Outcome should be the outcome used in sample size calculations, or the main outcome(s) used to determine the effects of the intervention(s). Enter the names of all primary outcomes in the trial as well as the pre-specified timepoint(s) of primary interest.
20	Key secondary outcomes	Key Secondary Outcomes	Secondary outcomes are events, variables, or experiences that are of secondary interest or that are measured at timepoints of secondary interest.

* From the final version released in February 2006